BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3955220 · Received July 24, 2014

    Report

    Report Number
    1031452-2014-04048
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER END USER 1,4 ERROR CODE. THE BATTERIES ARE OVERHEATING CAUSING THE ERROR CODE. THE END USER DIDN'T GIVE HER NAME AND DISCONNECTED DURING TRANSFER OF CALL. NO ADDITIONAL INFORMATION IS AVAILABLE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434930 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other